Background

Currently, electronic Instructions for Use (eIFUs) are only allowed for limited types of medical devices:

• If they are for professional use and use by other persons is not foreseeable:
  • Implantable and active implantable devices,
  • Fixed installed medical devices and their accessories, and
  • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.
• For software covered by the Regulation, the instructions may be provided in electronic format by means of the software itself.

In August 2024 the Commission opened a survey to collect feedback from professional users, on allowing eIFUs for all professional use medical devices. 87% of respondents stated they would prefer using eIFUs, if available to them.

The Update

The Commission published the draft to amend the eIFU regulation (Implementing Regulation (EU) 2021/2226): HERE

It proposes to expand the allowance of eIFUs to all professional use medical devices, presuming they meet the other requirements under the regulation, e.g., perform a documented risk assessment (Article 4); have a mechanism to provide paper IFUs upon request, at no cost to the user, and within 7 calendar days at the latest (Article 5(3)). The full list of proposed amendments is provided in the image below.

The feedback period is open from 21 February 2025 – 21 March 2025.

As noted here, Commission adoption is planned for Q2 2025. The amendment will enter into force on the 20^th day following its publication in the Official Journal of the EU (OJEU).